Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Is there a risk for Semaglutide Misuse? Focus on the Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) pharmacovigilance dataset

STEFANIA CHIAPPINI
* ORCID logo ,
Rachel Vickers-Smith
ORCID logo ,
Duccio Gabriele Papanti
,
John Martin Corkery
ORCID logo ,
Amira Guirguis
ORCID logo ,
Giovanni Martinotti
ORCID logo ,
Stefano L. Sensi
,
Fabrizio Schifano
Version 1 : Received: 8 June 2023 / Approved: 8 June 2023 / Online: 8 June 2023 (09:01:58 CEST)

A peer-reviewed article of this Preprint also exists.

Chiappini, S.; Vickers-Smith, R.; Harris, D.; Papanti Pelletier, G.D.; Corkery, J.M.; Guirguis, A.; Martinotti, G.; Sensi, S.L.; Schifano, F. Is There a Risk for Semaglutide Misuse? Focus on the Food and Drug Administration’s FDA Adverse Events Reporting System (FAERS) Pharmacovigilance Dataset. Pharmaceuticals 2023, 16, 994. Chiappini, S.; Vickers-Smith, R.; Harris, D.; Papanti Pelletier, G.D.; Corkery, J.M.; Guirguis, A.; Martinotti, G.; Sensi, S.L.; Schifano, F. Is There a Risk for Semaglutide Misuse? Focus on the Food and Drug Administration’s FDA Adverse Events Reporting System (FAERS) Pharmacovigilance Dataset. Pharmaceuticals 2023, 16, 994.

Abstract

Recent media reports commented about a possible antidiabetics’ misuse issue related to molecules promoted as a weight-loss treatment in non-obese people. We here evaluated available pharmacovigilance misuse/abuse signals related to semaglutide, a glucagon-like peptide-1 (GLP-1) analogue, in comparison to other GLP-1 receptor agonists (albiglutide; dulaglutide; exenatide; liraglutide; lixisenatide; tirzepatide) and the phentermine-topiramate combination. To that aim, we analysed the Food and Drug Administration-FDA Adverse Events Reporting System (FAERS) dataset, performing a descriptive analysis of adverse event reports (AER) and calculating related pharmacovigilance measures, including the reporting odds ratio (ROR) and the proportional reporting ratio (PRR). During January 2018-December 2022, a total of 31,542 AER involving the selected molecules were submitted to FAERS; most involved dulaglutide (n=11,858; 37.6%) and semaglutide (n=8,249; 26.1%). In comparing semaglutide vs the remaining antidiabetics, the AER ‘drug abuse’, ‘drug withdrawal syndrome’, ‘prescription drug used without a prescription’ and ‘intentional product use issue’ respective PRR values were 4.05, 4.05, 3.60 and 1.80 (all<0.01). The same comparisons of semaglutide vs the phentermine-topiramate combination were not associated with any significant differences. To our best, this is the first study documenting the misusing/abusing potential of semaglutide in comparison with other novel antidiabetics and the phentermine-topiramate combination. Current findings will need to be confirmed by further empirical investigations to fully understand the safety profile of those molecules.

Keywords

semaglutide; drug misuse; drug abuse; pharmacovigilance; image- and performance-enhancing (IPED) drugs; glucagon-like peptide-1 (GLP-1) agonists

Subject

Medicine and Pharmacology, Medicine and Pharmacology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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